Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

The effect of positioning on the transition from tube to oral feeding in preterm infants: A pilot study

Acronym

Study hypothesis

The effect of positioning on the transition from tube to oral feeding in preterm infants: A pilot study.

Ethics approval

Not provided at time of registration

Study design

Pilot RCT

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Positioning on the transition from tube to oral feeding in preterm infants

Intervention

This pilot study will take place on a local neonatal unit and will examine the bottle feeding skills of premature infants whilst they are being fed either an elevated side-lying position, or a traditional semi-upright position. Infants will be studied from the time that oral feeds are first introduced until the infant is taking all bottle feeds and the nasogastric tube is no longer required.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2005

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

At the time of first introduction to oral feeds, preterm infants (infants born with a gestational age of 36 completed weeks or less) will be randomly allocated to either the intervention or the control group. Randomisation will be my means of sealed envelopes containing either the words elevated side-lying position or traditional position. The aim is to have five participants in each group.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Infants will be excluded if they are medically unstable2. Have either a cleft lip or palate3. Have identified neurological symptoms4. Have congenital anomalies5. Have known maternal substance abuse6. Are to be discharged to other wards of hospitals before full oral feeding has been established7. Have a gestational age of 37 weeks or above8. Are being breastfed9. If it is not possible to explain the study adequately so that informed consent can be obtained then those infants will be excluded from the study. Informed consent will be obtained from the infants carers by either the researcher or a senior member of the nursing staff.

Recruitment start date

01/04/2005

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Child Development Centre
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health